Biological E Limited on Thursday announced that the Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) reviewed and approved the Phase 3 infants' clinical trial data and recommended for manufacture its 14-valent paediatric vaccine (investigational pneumococcal polysaccharide conjugate vaccine PCV14) against S pneumonia infection, in single-dose and multi-dose presentations.
A press release from the city-based vaccine maker said the PCV14 can be administered to infants at six, 10 and 14 weeks of age.
Streptococcus pneumoniae infection continues to be a leading cause of child mortality under 5 years of age in India and in developing countries.
With the PCV14 vaccine, BE hopes to contribute to the prevention of invasive pneumococcal disease and protect millions of lives globally.
The safety analysis of the vaccine revealed that all the adverse events were mild to moderate in their intensity and with no grade-3 & 4 events reported.
Mahima Datla, Managing Director, Biological E Limited said, ''We are delighted with this remarkable development. BE's PCV14 will protect millions of infants worldwide and contribute to the prevention of invasive pneumococcal disease.''
With this recommendation from SEC and the anticipated formal approval from Drugs Controller General of India (DCGI) thereafter, India will have yet another important lifesaving vaccine for paediatric use. Biological E would be also working with WHO and other global regulatory agencies to make this vaccine available globally, she added.
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